First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.

NCT07586618 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: The ALLiance Study5R44CA268530-02DP230071
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

ALT-101 is a first-in-human Phase 1 clinical trial testing a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. 4A10 is a targeted therapy designed to recognize and attach to a specific protein (CD127) found on leukemia cells. Once it binds, it works in two ways: it blocks growth signals that help cancer cells survive, and it helps the immune system find and destroy those cancer cells. In this study, patients receive 4A10 through an intravenous (IV) infusion once a week. The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look for early signs that the treatment may be working. The study starts with small groups of patients receiving increasing doses to carefully monitor safety. Each patient is closely observed during the first treatment cycle (about 4-6 weeks) to watch for side effects. If the treatment is helping and is well tolerated, patients may continue treatment for up to six cycles. Overall, this study is an early step in testing a new, targeted immune-based therapy for difficult-to-treat blood cancers.

Conditions

Lymphoblastic Lymphoma; Acute Lymphoblastic Leukemia ALL

Keywords

Leukemia; Refractory; Relapsed

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level

  Assessment of safety and tolerability of 4A10 as measured by the incidence, severity, and relationship of treatment-emergent adverse events, as graded by CTCAE v6, in participants receiving study treatment at each dose-level in the 3+3 dose escalation study design.

  Through study duration, an average of 1 year

• Determine the Recommended Phase 2 Dose (RP2D)/ Recommended Dose for Expansion (RDE) of 4A10 as a single agent in patients with R/R ALL/LL.

  Determination of the RP2D/RDE of ALT-101 based on evaluation of safety, tolerability, and available pharmacokinetic and pharmacodynamic data following dose-escalation.

  Through study duration, an average of 1 year

Secondary Outcomes (16)

• Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.

  Through study duration, an average of 1 year

• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.

  Through study duration, an average of 1 year

• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.

  Through study duration, an average of 1 year

• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.

  Through the study duration, an average of 1 year.

• Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.

  Through the study duration, an average of 1 year

Study Arms (1)

Single Arm

EXPERIMENTAL

Participants receive 4A10 administered by intravenous route according to the protocol-defined dosing schedule in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation per investigator decision.

Drug: 4A10

Interventions

4A10 DRUG

4A10 (Molecule B4532) is an investigational human Immunoglobulin G Subclass 1 (IgG1) monoclonal antibody that specifically binds CD127 (Interleukin-7 receptor alpha subunit, IL-7Rα). CD127 is a component of the interleukin-7 receptor and the thymic stromal lymphopoietin receptor (TSLPR), which are expressed on T-cell acute lymphoblastic leukemia (T-ALL) and pre-B-cell acute lymphoblastic leukemia (B-ALL) cells.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of T/B-ALL or T/B-LL
• Relapsed or refractory disease without curative options
• Adequate organ function and performance status

You may not qualify if:

• Patients with CNS3 disease
• Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)
• Prior exposure to anti-CD127 therapies
• Uncontrolled infections

Sponsors & Collaborators

• Allterum Therapeutics, Inc: lead
• National Cancer Institute (NCI): collaborator
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Schafer, MD

  Baylor College of Medicine

  STUDY CHAIR

Central Study Contacts

Shibani M Kudchadkar, MD

CONTACT

15153439875; skudchadkar@allterum.com

Yan Moore, MD, MBA

CONTACT

6178004959; ymoore@allterum.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

US (1)